Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response and Amendment Filed
Applicant’s response and amendment, filed November 17, 2025, has been entered and made of record.
Information Disclosure Statements
The information disclosure statements filed May 29, 2025 (2) and October 15, 2025 have been entered as the required filing fee under 37 CFR 1.17(p) has been filed. The references cited there have been considered by the examiner.
Previously Set Forth Objections and Rejections
The objection to the drawings under 37 CFR 1.83(a) as set forth in the previous Office action is hereby maintained and is reiterated below.
The 35 USC 102(a)(2) rejection of claims 1-4, 6-10 and 12 as being anticipated by Govari et al. (U.S. Patent Application Publication No. 2023/0084207) is hereby withdrawn.
The 35 USC 102(a)(2) rejection of claims 1-3 and 5 as being anticipated by Quinn et al. (U.S. Patent No. 10,376,170) is hereby withdrawn.
The 35 USC 103 rejection of claims 7-9 and 11 as being unpatentable over Quinn et al. (U.S. Patent No. 10,376,170) is hereby withdrawn.
The following new and reiterated objections and grounds of rejection are set forth:
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “set of spray ports” as recited in claims 7 and 12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Contrary to applicant’s arguments at page 6 of the response filed November 17, 2025, the test is not whether illustration of the “set of spray ports” is necessary for understanding the invention, it is whether the “set of spray ports” are recited in the claims. MPEP 608.02(d) and 37 CFR 1.83(a) make it clear that the drawings must show every feature of the invention specified in the claims. The “set of spray ports” is recited in claims 7 and 12. Therefore, they must appear in the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claim 14 recites “wherein the sleeved outlet comprises a changing profile along a circumference of the irrigation tube.” Applicant points to paras. 0014, 0024-00251 and the drawings for support for this new recitation. However, a careful reading of this sections indicates that the recited structure is neither discussed nor depicted in the disclosure. Accordingly, this recitation constitutes new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitation of “changing profile along a circumference” is vague and indefinite. It cannot be determined what applicant is intending to claim, particularly since the language of claim 14 is not supported by the disclosure (see above).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-7 and 11-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tegg et al. (U.S. Patent No. 9,339,331).
In regard to claims 1 and 7, Tegg et al. teach a catheter system 10 comprised of a basket catheter 25 having an outer tubing 30 housing an inner fluid delivery tubing 32 and a deployment member 31 (see Figs. 2a-2b). Tegg et al. teach fluid control valves 1-3 for introduction of irrigation from and irrigation source (see Fig. 1; see also col. 6, lines 27-50). The basket catheter 25 includes a plurality of splines 36 and each spline 36 is connected at its distal end to deployment member 31 (see Figs. 2a-3b and col. 5, lines 39-42). Each spline 36 includes a plurality of electrodes 58 (see Figs. 5a-5b and col. 7, line 58 to col. 8, line 3). Figure 2b shows that the deployment member 31 extends along a longitudinal axis from a distal end of the fluid delivery tube 32 to the distal end of the basket catheter 25. With further respect to claim 7, Tegg et al. do not specifically disclose a method of using the device. However, this recitation is considered an intended use recitation that is given little patentable weight. Moreover, the structure recited by Tegg et al. does not include any structural limitations that would preclude its use is the recited method and thus, the device taught by Tegg et al. is capable of being used in the recited method. It should be noted that it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In regard to claims 3 and 9, Tegg et al. teach that the electrical wiring 59 may convey signals between the electrodes 58 (see col. 8, lines 9-15). In regard to claims 5, 6, 11, 12 and 15, Tegg et al. teach that fluid delivery tubing 32 has a plurality of fluid delivery ports 34a-b that, as broadly as claimed, constitute tubules. (see Fig. 2b and col. 5, lines 27-38). In regard to claim 13, Tegg et al. teach that the fluid delivery tube 32 extends distally from a distal end of the outer tubing 30 and is located proximally to the electrodes 58 and has a distal face perpendicular to the longitudinal axis of the tubing 30 (see Fig. 2b). In regard to claim 14, as broadly as claimed, the ports 34a-34b provide the fluid delivery tube 32 with a changing profile along a circumference of the tube 32 (see Fig. 2b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 4, 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg et al. (U.S. Patent No. 9,339,331) in view of Heisel et al. (U.S. Patent Application Publication No. 2018/0042672).
In regard to claims 2, 4, 8 and 10, Tegg et al. are silent as to the electrodes 58 being non-overlapping in the collapsed state or staggered between splines. However, Heisel et al. teach a basket-type electrode assembly 12 having struts 20 with electrodes 22, 24, 26 and 28 mounted thereon (see Fig. 3). Figure 3 shows that the electrodes 22, 24, 26 and 28 are staggered and non-overlapping when the electrode assembly 12 is collapsed. Heisel et al. thus demonstrate that non-overlapping, staggered electrodes on a basket assembly are well known in the art and provide a means for having non-overlapping of the electrodes in the collapsed state of the basket. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Tegg et al. with non-overlapping, staggered electrodes 58, in the manner disclosed by Heisel et al., in order to equip with device with the ability to have the electrodes not overlap when the basket is collapsed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
1 Ostensibly applicant is referring to paras. 0014 and 0024-0025 of the related PG Publication No. 2024/0216043 as the specification filed in the instant application does not contain paragraph numbers.